Daiichi Sankyo


Concise Prescribing Info
Acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired & nosocomial pneumonia, complicated & mild to moderate uncomplicated skin & skin structure infections (SSSI) (including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections), mild to moderate complicated & uncomplicated UTI, mild to moderate acute pyelonephritis, chronic bacterial prostatitis.
Dosage/Direction for Use
250 or 500 mg orally or by slow infusion over 60 min every 24 hr or 750 mg by slow infusion over 90 min every 24 hr. Acute bacterial exacerbation of chronic bronchitis 500 mg every 24 hr for 7 days. Community-acquired pneumonia 500 mg every 24 hr for 7-14 days. Nosocomial pneumonia, complicated SSSI 750 mg every 24 hr for 7-14 days. Acute bacterial sinusitis 500 mg every 24 hr for 10-14 days. Uncomplicated SSSI 500 mg every 24 hr for 7-10 days. Complicated UTI, acute pyelonephritis 250 mg every 24 hr for 10 days. Uncomplicated UTI 250 mg every 24 hr for 3 days. Chronic bacterial prostatitis 500 mg every 24 hr for 28 days. Renal impairment: Acute bacterial exacerbation of chronic bronchitis/community-acquired pneumonia/acute maxillary sinusitis/uncomplicated SSSI: CrCl 20-49 mL/min Initially 500 mg then subsequently, 250 mg every 24 hr, CrCl 10-19 mL/min, hemodialysis, CAPD Initially 500 mg then subsequently, 250 mg every 48 hr. Complicated SSSI: CrCl 20-49 mL/min Initially 750 mg then subsequently, 750 mg every 48 hr, CrCl 10-19 mL/min, hemodialysis, CAPD Initially 750 mg then subsequently, 500 mg every 48 hr. Complicated UTl/acute pyelonephritis: CrCl 10-19 mL/min Initially 250 mg then subsequently, 250 mg every 48 hr.
May be taken with or without food: May be taken during or between meals. Take at least 2 hr before or after Fe salts, antacids & sucralfate. Ensure adequate fluid intake.
Patients w/ history of hypersensitivity to levofloxacin or other quinolones.
Special Precautions
Discontinue immediately at the 1st appearance of a skin rash or any other sign of hypersensitivity; if patient experiences peripheral neuropathy symptoms. Patient w/ known risk factors for QT interval prolongation [eg, congenital long QT syndrome, concomitant use of QT interval prolonging drugs (eg, class IA & III antiarrhythmics, TCAs, macrolides & antipsychotics), uncorrected electrolyte imbalance (eg, hypokalaemia, hypomagnesaemia), elderly, cardiac disease (eg, heart failure, MI, bradycardia)]. Patient w/ known history of myasthenia gravis; known or suspected CNS disorder that may predispose to seizures or lower seizure threshold. May increase intracranial pressure & CNS stimulation (following the 1st dose) which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia & rarely, suicidal thoughts or acts. Consider diagnosis of pseudomembranous colitis in patients who present diarrhea following treatment. Discontinue if patient experiences pain, inflammation, or tendon rupture; rest & refrain from exercise until diagnosis of tendinitis or tendon rupture has been confidently excluded. Maintain adequate hydration. Avoid excessive exposure to sunlight; discontinue if phototoxicity occurs. Monitor blood glucose of diabetics receiving concomitant treatment w/ an oral hypoglycemic (eg, glyburide, glibenclamide) or w/ insulin; immediately discontinue & initiate appropriate therapy, if a hypoglycemic reaction occurs. Periodically assess organ system functions, including renal, hepatic & hematopoietic during therapy. May cause neurologic adverse effects (eg, dizziness, lightheadedness) that may impair ability to drive or operate machinery or engage in other activities requiring mental alertness & coordination. Renal impairment (CrCl <50 mL/min). Pregnancy & lactation. Childn <18 yr (potential arthropathy & osteochondrosis). Elderly. Infusion: Not for IM, intrathecal, intraperitoneal or SC administration. Avoid rapid or bolus IV infusion. Should only be administered by slow IV infusion over a period of 60 or 90 min depending on the dosage.
Adverse Reactions
Nausea, diarrhea, vaginitis, insomnia, abdominal pain, flatulence, pruritus, dizziness, dyspepsia, rash, genital moniliasis, taste perversion, vomiting, constipation, fungal infection, genital pruritus, headache, moniliasis, nervousness, rash erythematous, urticaria; pain, sinusitis, rhinitis, chest & back pain, fatigue. Infusion: Inj site reaction, pain & inflammation.
Drug Interactions
Patients receiving known QT interval prolonging drugs (eg, class IA & III antiarrhythmics, TCAs, macrolides, antipsychotics). GI absorption may be interfered by antacids containing Mg, Al, sucralfate, metal cations eg, Fe, & multivit prep w/ Zn. Potential prolonged elimination t½, elevated serum theophylline levels & subsequent increase in risk of theophylline-related reactions. Elevations of prothrombin time in concurrent use w/ warfarin. May increase the risk of CNS stimulation & convulsive seizures w/ NSAIDs. Blood glucose disturbances (hyper- & hypoglycemia) w/ antidiabetic agents.
MIMS Class
ATC Classification
J01MA12 - levofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Cravit IV infusion 250 mg/50 mL
Cravit IV infusion 500 mg/100 mL
Cravit tab 250 mg
Cravit tab 500 mg
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